XIENCE ALPINE 1125250-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648199196), received between Aug 17, 2016 and Mar 1, 2021 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2021Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MILD TORTUOSITY IN THE OBTUSE MARGINAL CORONARY ARTERY. THE 2.5 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE LESION BUT COULD NOT CROSS THE TIGHT LESION AND IT WAS NOTED THAT THE STENT SHIFTED DISTALLY. THE SDS WAS REMOVED WITH THE STENT. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT THE STENT STILL REMAINED ON THE BALLOON AND THAT THE PROXIMAL END OF THE STENT HAD FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11392395 ↗
• InjuryOct 10, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 2.5X28MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION; HOWEVER, IT FAILED TO CROSS DUE TO THE ANATOMY. AN ATTEMPT TO REMOVE THE SDS WAS MADE, BUT IT WAS STUCK WITH THE HEAVY CALCIFICATION AND THE STENT DISLODGED. A 1.2MM UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND THE STENT WAS PARTIALLY EXPANDED TO STABILIZE IT ON THE GUIDE WIRE. A SNARE DEVICE WAS ADVANCED AND USED TO SUCCESSFULLY RETRIEVE THE STENT INTO THE GUIDING CATHETER. THE DISLODGED STENT AND GUIDING CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A 3.0X26MM AND 3.0X12MM NON-ABBOTT STENTS. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953432 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2.5 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND RENAL FAILURE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Renal Failure

  MAUDE report 7865915 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A 2.5 X 28 MM MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR SEPSIS AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 7845812 ↗
• MalfunctionJul 17, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT ON REMOVAL OF A 2.50X28MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FROM THE DISPENSER COIL, RESISTANCE WAS FELT. ADDITIONAL RESISTANCE WAS ALSO FELT ON REMOVAL OF THE PROTECTIVE SHEATH OF THE SDS AND THE STENT STRUTS WERE NOTED TO BE FLARED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL XIENCE ALPINE SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7696721 ↗
• InjuryMay 8, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, RIGHT CORONARY ARTERY (RCA), THE 2.5 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS USED WITH A NON-ABBOTT GUIDELINER CATHETER AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. WHILE RETRACTING THE SDS, RESISTANCE WAS MET WITH THE GUIDELINER AND THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. AFTER THREE ATTEMPTS THE STENT WAS SUCCESSFULLY SNARED AND REMOVED FROM THE LEFT INTERNAL ILIAC ARTERY WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497037 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). TWO XIENCE ALPINES STENTS (2.75 X 23 MM AND 3.0 X 08 MM) WERE IMPLANTED IN THE LAD AND THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE RCA. THE PATIENT WAS GIVEN ANGIOMAX. THE PROCEDURE WENT WELL; HOWEVER, WHEN BEING TAKEN TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT WENT INTO CARDIOGENIC SHOCK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE AN INTRA-AORTIC BALLOON PUMP WAS PUT IN AND THEN THROMBOSIS WAS OBSERVED IN ALL FIVE STENTS. THE THROMBOSIS IN THE PROXIMAL LAD AND THE RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND THE MID LAD WAS TREATED WITH TWO NON-ABBOTT STENTS. THE PATIENTS MEDICATION WAS CHANGED TO INTEGRILIN AND IS NOW STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Thrombosis

  MAUDE report 7169124 ↗
• MalfunctionJun 13, 2017Leak/Splash; Difficult To Position; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. AFTER SUCCESSFUL PLACEMENT OF TWO XIENCE ALPINE STENTS, THE 2.5 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ON THE GUIDE WIRE, WHEN IT ENTERED THE SHEATH IT WOULD NOT ADVANCE ANY FURTHER. THE SDS WAS REMOVED FROM THE GUIDE WIRE WITHOUT ISSUE AND A NEW SDS WAS USED SUCCESSFULLY WITH THE SAME GUIDE WIRE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED A 2 MM TEAR AND LEAK AT THE GUIDE WIRE EXIT NOTCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6638908 ↗
• MalfunctionFeb 17, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKAGING AND PRIOR TO PREP, WHILE IT HAD BEEN CONFIRMED THAT THE DEVICE WAS SEALED IN ITS PACKAGING, A 2.5X28MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PULLED OUT OF ITS DISPENSER HOOP WITHOUT DIFFICULTY AND THE PROTECTIVE SHEATH WAS REMOVED WITHOUT DIFFICULTY WHEN IT WAS NOTED THAT THE STENT WAS MISSING FROM THE BALLOON. THE STENT WAS FOUND TO BE LOCATED INSIDE OF THE DISPENSER HOOP. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER XIENCE ALPINE WAS UNPACKAGED WITHOUT ISSUE AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6339512 ↗
• InjuryJan 4, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY TORTUOSITY AND MILD CALCIFICATION. THE 2.50 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION DURING A DIRECT STENTING PROCEDURE, BUT IT WAS UNABLE TO CROSS THE BEND IN THE LEFT MAIN. WHEN THE SDS WAS REMOVED FROM THE ANATOMY, THE STENT IMPLANT DISLODGED FROM THE SDS AND REMAINED IN THE LEFT MAIN ARTERY. THERE WAS NO RESISTANCE WHILE REMOVING THE SDS. A SNARE DEVICE WAS USED TO RECOVER THE STENT; HOWEVER, THE STENT WAS UNABLE TO BE PULLED THROUGH THE GUIDING CATHETER. RADIAL ARTERIAL CUT DOWN WAS PERFORMED TO REMOVE THE DISLODGED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6221774 ↗
• InjuryOct 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2015 A 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A 2.5X28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE SECOND DIAGONAL OF THE LAD. ON (B)(6) 2015 THE PATIENT RETURNED WITH CHEST PAIN AND HIGH BLOOD PRESSURE. A 3.25X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE OBTUSE MARGINAL (OM) ARTERY AND A 3.5X33 MM XIENCE ALPINE WAS IMPLANTED IN THE PROXIMAL LAD ACROSS THE DISEASED SEGMENTS INTO THE PREVIOUSLY PLACED STENT. THE PATIENT HAS HAD SEVERAL ANGIOGRAMS PERFORMED DUE TO CONTINUED CHEST PAIN, ONE IN IN (B)(6) 2016, (DATE NOT SPECIFIED FOR (B)(6)) AND ON (B)(6) 2016, ANGIOGRAMS HAVE CONFIRMED ALL FOUR STENTS REMAIN PATENT. ROUTINE MEDICATION WAS GIVEN FOR ANGINA AND FOR HYPERTENSION. THE PATIENT IS CONCERNED THAT SHE IS POSSIBLY ALLERGIC TO THE STENTS WHICH COULD BE CAUSING THE CHEST PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction

  MAUDE report 6065088 ↗
• MalfunctionOct 13, 2016Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE 2.5X28 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS). THE SDS WAS ADVANCED TO THE HEAVILY TORTUOUS, MODERATELY CALCIFIED MID LEFT CIRCUMFLEX CORONARY ARTERY AND INFLATED TO 12 ATMOSPHERES. IT WAS THEN NOTED THAT THE STENT WAS NOT ON THE SDS. THE PATIENT WAS CHECKED FOR A DISLODGED STENT WITH MULTIPLE CINE VIEWS AND OCT, BUT THE STENT WAS NOT FOUND IN THE PATIENT. ANOTHER XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. WHEN THE PROCEDURE WAS COMPLETED, THE STENT WAS FOUND INSIDE THE SHEATH. THE STENT HAD COME OFF THE SDS WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6028899 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X28 RX XIENCE ALPINE WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO UNSTABLE ANGINA (CHEST PAIN). THE PATIENT WAS ADMINISTERED AN UNSPECIFIED FORM OF TREATMENT THEN DISCHARGED HOME. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5984916 ↗
• MalfunctionSep 28, 2016Difficult To Position; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.5 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE GUIDE WIRES BEING USED IN A BUDDY TECHNIQUE AND WOULD NOT CROSS THE LESION RESULTING IN FLARED STENT STRUTS. A NEW SAME SIZE SDS WAS USED WITHOUT ANY FURTHER ISSUE TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE GUIDE WIRE EXIT NOTCH WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5984307 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X28MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5958281 ↗
• InjuryAug 17, 2016Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH NO TORTUOSITY AND HEAVY CALCIFICATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) HAD DIFFICULTIES ADVANCING TO THE TARGET LESION DUE TO THE PATIENT ANATOMY. THEREFORE, THE SDS WAS WITHDRAWN; HOWEVER, THE STENT GOT CAUGHT WITH THE GUIDELINER AND THE STENT DISLODGED. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT SUCCESSFULLY. THE PATIENT WAS TAKEN FOR CORONARY ARTERY BYPASS SURGERY DUE TO THE HEAVILY CALCIFIED LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5883206 ↗